Better 8 years late than never: Merck KGaA nabs FDA nod for MS drug Mavenclad

FDA | April 01, 2019

Up to 10 years of safety data has paid off for Merck KGaA’s oral multiple sclerosis treatment Mavenclad. The drug has returned from the dead, eight years after an FDA rejection dashed its dream of challenging Novartis’ then-newly-minted Gilenya—and according to one analyst, it might just be a blockbuster. Maveclad (cladribine) is now approved to treat relapsing forms of MS, including relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS), the FDA said Friday. The agency's green light came after more than 50 other countries, including in the EU, had approved it. The Merck drug does carry a black box warning for an increased risk of cancer and birth defects, which pushed its FDA-approved use into the second line—in patients who don’t respond to or are unable to tolerate other MS drugs. But as Bernstein analyst Wimal Kapadia sees it, the safety profile is no reason to belittle Mavenclad’s success potential.

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BUSINESS INSIGHTS

Teva Reaches Agreement With Texas to Settle the State’s Opioid-Related Claims

Teva Pharmaceuticals | February 08, 2022

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. and its affiliates, has reached an agreement with the Attorney General (AG) of Texas that settles the state’s and its subdivisions opioid-related claims. Under the terms of the settlement, Teva will pay Texas $150 million over a 15-year time period and will provide the recently launched, lifesaving medicine generic Narcan®, valued at $75 million over 10 years. “Expanding access to lifesaving medicines is at the core of Teva’s mission. The Texas Attorney General is taking steps to address the opioid epidemic in the State by negotiating a settlement that includes critical medicines as part of their solution. While the settlement includes no admission of wrongdoing by Teva or its affiliates, it remains in the best interest of Teva to put these cases behind us and continue to focus on the patients we serve every day.” Kåre Schultz, Teva’s President and CEO Naloxone is a life-saving medication that can reverse an overdose from opioids.1 As of December 2021, Teva has made available the first generic version of this critical medicine and has included this product in the Company’s ongoing pursuit of a national or narrower settlement with individual states such as the deal announced today. The Company will continue to defend itself in court in states where we have not reached terms of a settlement agreement. Teva believes that today’s settlement with the state of Texas is a critical step forward in getting life-saving treatments to people suffering from opioid addiction. About Teva Teva Pharmaceutical Industries Ltd. has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products.

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BUSINESS INSIGHTS

CCT Research Announces New Partnership with BEKHealth

CCT Research | February 18, 2022

CCT Research has announced an exciting partnership with BEKHealth. The collaboration streamlines access to electronic medical records (EMR) data, across CCT sites and drives a data-driven approach to trial execution and management. CCT has established itself as an innovator in conducting clinical trials. Using BEKHealth, a provider of software solutions for enhancing clinical research processes, will enable CCT to more accurately identify and fit studies to its sites. The deep commitment by both companies to improving the outcomes of clinical trials made the relationship a natural fit. “One of CCT’s driving forces is to promote an environment of innovation and continuous improvement. Our partnership with BEKHealth strengthens our ability to identify potential research participants, ultimately creating greater accessibility to clinical trials.” Jennifer Kocour, President, CCT Research More than just a “technology” partnership, this collaboration with BEKHealth is also patient-centric– which remains a top priority for CCT. Once studies are awarded, it will power onsite research by identifying patients who fit studies best, saving sites, patients, and staff time and hassle. “At the individual site level, our goal is to optimize research to be as beneficial to the practice and its patients as possible with minimal disruption to the clinics day-to-day operations. We view data and technology as central to that strategy and couldn’t be more excited to work with BEKHealth,” said Kyle McAllister, Vice President, Data & Analytics, CCT Research. “The breadth and depth of CCTs network was an exciting opportunity. The ability to leverage technology to centralize key drivers of success such as feasibility, site selection, patient recruitment and analytics drives a new paradigm in clinical research,” said Jason Baumgartner, CEO and Founder, BEKHealth. “Our platform is secure and activation creates a minimal burden on IT teams. What this means for the provider and patient is our collaboration will have a major impact quickly.” “We provide an integrated clinical operating platform that enables companies to streamline research across multiple key processes,” said Josh Ransom, PhD, Vice President, Customer Experience, BEKHealth. “Ultimately this means our partners can scale their businesses faster by improving operational efficiency while taking out manual and inefficient steps.” About CCT Research CCT Research is a network of clinical research sites embedded in the offices of skilled physicians conducting clinical trials to offer patients with innovative medical treatments and safe, effective care options. CCT Research was founded in 2017 and has more than 20 locations across Arizona, Georgia, Kentucky, Nebraska, Nevada, and Utah. The sites are located within physicians’ offices, within ACO networks, and several dedicated research centers. CCT supports research in Neurology, Family Practice, and Dermatology, with plans to include additional therapy areas soon. The company's unique model simplifies the process for trial participants and provides pharmaceutical sponsors with high-quality data.

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PHARMACY MARKET

Nobel Biocare Receives FDA 510(k) Clearance for the Nobel Biocare N1™ Implant System

Envista Holdings Corporation | December 28, 2021

Envista Holdings Corporation announced that the U.S. Food and Drug Administration has cleared the Nobel Biocare N1™ implant system. Boasting a biologically driven design of components and forward-thinking treatment protocols, the N1™ implant system represents a significant step forward in patient-centric implant solutions. More than an implant, N1 is a comprehensive system of dedicated instruments, prosthetic components, and surgical protocols. New features of the system include an implant designed for immediate placement and predictable insertion torques, a trioval conical connection for the abutment to slide into place, and an emergence profile designed for soft tissue maintenance. Innovative site preparation for greater patient comfort The Nobel Biocare N1™ system includes the novel feature of the OsseoShaper™, an instrument that redefines site preparation and is set to reshape implantology with optimized workflows, greater patient comfort and faster treatment times. By gently 'shaping' the osteotomy at low speed and without irrigation, the OsseoShaper™ reduces noise and vibration compared to conventional drilling protocols. This leads to improved patient comfort and has been shown in pre-clinical studies to preserve vital bone. Embracing surface chemistry and digital workflows Fully embracing the new Mucointegration™ concept, the Nobel Biocare N1™ features the Xeal™ and TiUltra™ surface treatments. With their specially tailored surface chemistry and topography, TiUltra implants and Xeal abutments can benefit from this design to optimize tissue integration at every level. Nobel Biocare N1™ will be further integrated into the digital workflow with the DTX Studio™ suite, giving dental professionals more opportunities to provide patients with shorter time to teeth. "For over 50 years, Nobel Biocare has been a pioneering force behind implantology. The demand for high quality patient-centric solutions is higher than ever, and the Nobel Biocare N1™ system enables clinicians to set a new standard in personalizing, digitizing, and democratizing the implant treatment experience they can offer patients." Amir Aghdaei, Chief Executive Officer, Envista Patrik Eriksson, President Nobel Biocare, explained, "Drilling protocols have hardly changed over the past 50 years. However, the OsseoShaper™ provides a completely new approach designed for patient comfort, streamlined workflow, and improved predictability; while at the same time, respects biology to achieve fast osseointegration. We are excited to partner with clinicians to bring the N1 system to US-based patients." About Nobel Biocare Nobel Biocare is a world leader in the field of innovative implant-based dental restorations. The company's portfolio offers solutions from single tooth to fully edentulous indications with dental implant systems (including key brands NobelActive® and NobelParallel™ and ceramic implant NobelPearl™*) a comprehensive range of high-precision individualized prosthetics and CAD/CAM systems (NobelProcera®), digital solutions for treatment planning and guided surgery (NobelClinician® and DTX Studio™ suite) as well as biomaterials. Nobel Biocare supports its customers through all phases of professional development, offering world-class training and education along with practice support and patient information materials. The company is headquartered in Zurich, Switzerland. Production takes place at five sites located in the United States, Sweden, and Germany. Products and services are available in over 80 countries through subsidiaries and distributors. *Distributed by Nobel Biocare. Manufactured by Dentalpoint AG About Envista Envista is a global family of more than 30 trusted dental brands, including KaVo, Kerr, Nobel Biocare, and Ormco, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. With a foundation comprised of the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus, Envista is well equipped to meet the end-to-end needs of dental professionals worldwide. Envista is one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry.

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PHARMA TECH

Aquavit Further Prevails Against Counterfeiters in U S Following its Recent Victory in Europe

Aquavit Pharmaceuticals, Inc | March 22, 2022

Aquavit Pharmaceuticals, Inc continues to succeed in its intellectual property cases against counterfeiters both domestically and abroad. Following a recent win against counterfeiter U-BioMed, Inc. across the European Union, the U.S. Southern District Court of New York adopted Judge Lehrburger's recommendations that any sanctions related to U-BioMed's deletion of its Instagram account, which blatantly exploited Aquavit's AQUAGOLD product illegally, be folded into the pre-existing sanctions requiring U-BioMed to pay Aquavit's reasonable legal fees and costs associated with the sanctions-related motions. The Court further reinforced Lehrburger's preview award ordering U-BioMed to pay attorney fees and costs to Aquavit in compensatory damages. U-BioMed's continuous violation of the court's order in 2019 has to date accumulated the court's coercive sanction to millions of dollars. "The depths to which counterfeiters have gone to exploit Aquavit's patented technology, confuse customers, and attempt to trick the legal system(s) is criminal, especially with FDA regulated medical devices. It is of the utmost importance that we protect our physicians from liability and misinformation and continue to keep our patients safe." Sobin Chang, CEO of Aquavit Aquavit's victorious claim against U-BioMed with the European Union Intellectual Property Office (EUIPO) has set a significant milestone. The court acknowledged that U-BioMed knowingly and intentionally filed an infringing trademark application with the EUIPO for the mark "AQUAGOLD Fine Touch". "The counterfeits appear almost identical to the naked eye; however, they do not contain the microchannels as they claim and are often made of regular steel that are not biocompatible under the FDA's medical device material guidelines. Furthemore, they infringe on our 'repeated motion' drug delivery utility patent (U.S. Patent No . 10,980,865) for any drugs, components or biologics." says Dr. David Shafer, Aquavit's Chief Medical Technology Officer. The EUIPO has declared U-BioMed's actions to be willful and done purposefully in an effort to confuse consumers with Aquavit's already existing AQUAGOLD products being sold globally. The EUIPO issued a cancellation of U-BioMed's infringing mark, upheld Aquavit's application for a declaration of invalidity, and held U-Biomed accountable for the legal costs in the European Union. About Aquavit Aquavit is a high-tech pharmaceutical company that provides a comprehensive range of innovative pharmaceutical, biotech and medical device technologies. Aquavit focuses on personalized medicine to improv.

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